The disclosure relates generally to the field of sample assaying devices, which can be used to manipulate samples, including samples used to assay for analytes, especially drugs of abuse, antibodies, antigens and biological moieties such as steroids and glucose. In particular, the disclosure relates to improvements in assay device design that provide and true positive and negative control for each analyte of interest, to be used in a clinical setting.
In the drug of abuse testing industry, various governmental agencies and professional organizations, such as but not limited to CLIA CAP, COLA and JCCHO, have initiated regulations to ensure quality control and standardization of testing with point of care devices. For example, these agencies and organizations may require certain positive, negative or procedural controls to be run at the beginning of the day, or the beginning of a new lot of devices. No point of care test devices currently on the market have true positive and negative controls, to which the test results obtained with the test sample can be compared, creating an ongoing and existing need.